8:00 am Registration & Coffee Networking

8:50 am Chair’s Opening Remarks

  • Max Tejada Executive Director, Head of Analytical Development, Kite Pharma

9:00 am Industry Leaders Fireside Chat: Deploying Potency Assays for Cell Therapeutics – Key Considerations and Challenges

  • Zhu Pirot CGT Analytical Lead, Bayer
  • Donna Rill Chief Technology Officer, Triumvira Immunologics

Synopsis

• What can we make of the current regulatory guidelines and what are the key takeaways from recent guidances?
• Lessons learned and analytical strategy from experts in the cell therapy field

9:30 am Decoding Current Guidelines for Potency Regulations to Move Towards Industry Standards

  • Joseph Lee Senior Director, Product Sciences, Affini-T Therapeutics

Synopsis

• Establishing regulatory requirements for assays to meet regulatory standards
• Answering the question ‘what are regulatory agencies looking for?’
• Providing valuable lessons learnt from time spent in the cell therapy space

10:00 am Real-Time Measurement of Immune Cell Killing and Cell Metabolic Fitness and Persistence: Robust Assays Meeting the Demands of Cell Therapy Discovery, Process Development and QC/Release Criteria

  • Yama Abassi Head of Strategic Marketing and Business & Applications Development, Agilent Technologies

10:30 am Morning Break & Structured Networking

Synopsis

As the cell therapy community is reunited, this valuable session will ensure you can connect with your peers in the room to make new and lasting connections. Also, don’t forget to enjoy some refreshments before we come back after the break!

Integrating Potency Strategies from Early Development to Facilitate Success

11:30 am Data Driven Approaches to the Development and Qualification of Phase Appropriate Potency Assays

  • Lena Vasserman Associate Director, Analytical Development, Turnstone Bio

Synopsis

• Addressing the need for emphasis on potency in early stages to front load against regulatory kickback
• Delineating the differences in expectations from Phase 1 through to commercial validation
• Trending and understanding the data leading to successful development and validation for potency assays

12:00 pm Streamline Potency Testing with Maestro Z: Next Generation Cell Analysis Platform

  • Stacie Chvatal Senior Product Manager, Bioelectronic Assay Systems, Axion BioSystems

Synopsis

• Label-free cell growth and killing assays
• One platform for every step of development
• Save time, cut costs, and simplify your workflow

12:30 pm Strategies for Developing a Potency Assay for a Clonal Neoantigen-Reactive Cell Therapy Product

Synopsis

• Showcasing options for measuring potency effectively
• Discussing data generation in Phase I trials
• Transition from early stage to late-stage development for potency assays
• Supporting characterization and development by designing phase appropriate potency assay

1:00 pm Lunch Break & Networking

Next Generation of Potency Assays to Advance Clinical Efficacy

2:00 pm Next Generation Potency Testing –Moving from Surface Markers and Flow Cytometry to Omics Approaches

  • Bo Yan Associate Director, Analytical Sciences, Beam Therapeutics

Synopsis

  • Multiple assays using orthogonal techniques to measure different aspects of potency are often necessary for cell therapy drug products
  • Phase appropriate considerations in assay development using surface markers and omics approaches
  • Utilizing omics in early stages may lead to better understanding of mechanism of action and drug products

2:30 pm HiBiT: A Tiny Tag to Assess MOA-based CAR-T Cell Potency

  • Mei Cong Research Director, Promega Corporation

Synopsis

• A novel HiBiT Target Cell Killing (TCK) platform to measure CAR-T cell potency
• The live cell HiBiT assay measures specific killing of target cells
• CAR-T cell potency will be demonstrated using this simple, homogenous, highly sensitive and robust assay platform

2:40 pm Considering the Potency Assays in Gamma Delta T Cell Therapies

Synopsis

• Discussing the need for golden standard reference material and considering alternative options when none are available
• Asking the question ‘what type of cell lines to use as target material for the cytotoxicity assay? Is there a standard?’
• The mechanism of action via cytotoxicity assays as well as considering single cell cytokine profiles for gamma delta T cells

3:10 pm Afternoon Break & Refreshments

Discussing Potency Guidelines to Understand the Regulatory Environment

4:00 pm Mechanism of Action, Potency & Clinical Efficacy

  • Carl Simon Biologist, National Institute of Standards & Technology

Synopsis

• Defining mechanism of action, potency & clinical efficacy
• Measuring mechanism of action, potency & clinical efficacy
• Can a product be potent but not clinically efficacious?

4:30 pm Relating Potency Assay Studies to Clinical Efficacy

Synopsis

• Asking the question among all the different potency assays, which ones tend to be correlated with clinical efficacy?
• Considerations for assay development

5:00 pm Chair’s Closing Remarks

  • Max Tejada Executive Director, Head of Analytical Development, Kite Pharma